Nobody would get into a self-driving car simply because the door locks worked and the alarm system was functioning properly. Those security features protect the car from being stolen or tampered with, but they say nothing about whether the car’s AI will stop in time when a child runs into the road, or know when it’s safe to proceed at a four-way stop.

Data security alone won’t cut it

The same principles apply to AI systems in life sciences. Data security ensures your information is protected, your access is controlled, and your systems are hardened against attack. It’s critical and foundational, but it only protects the information flowing through your AI.

Your security posture says nothing about the decisions your AI is making with that information. The hard truth is that a perfectly secured system can still produce an unsafe outcome when decisions are made with AI. The gap between security and AI governance is what ISO 42001 was designed to fill.

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